AsthmaPhase 2NCT02422121
Effect of RNS60 on the Late Phase Asthmatic Response to Allergen Challenge
A Phase 2 study testing RNS60 in people with Asthma, run by Revalesio Corporation at 1 site in United Kingdom.
Trial summary
The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1 will be measured after an inhaled allergen challenge at baseline and again after 21 days of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- RNS60
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able and willing to give written informed consent;
- Male and female subjects aged 18 to 65 years inclusive.
- Subjects with a body weight ≥50 kg and a BMI between 18.0 and 32.0 kg/m2 inclusive at screening.
- Subjects should be steroid-naïve (within 3 months of screening for oral corticosteroids and within 28 days of screening for inhaled corticosteroids) with mild asthma and satisfy the Global Initiative for Asthma (GINA) definition of asthma, but be otherwise healthy.
- Male subjects should agree to not donate sperm from first dose until 3 months post-last dose.
- Male subjects (with female partners of child bearing potential) and female subjects of child bearing potential should use two methods of highly effective contraception.
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- Subjects should be non-smokers or ex-smokers for at least 12 months with less than a 10 pack year history.
- Subjects should not take any concomitant anti-asthma (except short-acting inhaled β2-agonists [SABAs]) or anti-allergy medication for at least 6 weeks prior to the screening visit and throughout the study period. Antihistamines will be permitted up to 7 days prior to the first screening visit.
- Pre-bronchodilator FEV1 of ≥70% of the predicted normal value for age, height and sex at screening and prior to first dose administration.
- Positive methacholine with a provocative concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of equal to or less than 8 mg/mL at screening.
- Documented allergy to at least one common allergen (house dust mite, grass pollen allergens or cat dander) as confirmed by a skin prick test wheal (≥3 mm in diameter). Historical data (up to 1 year) may be used.
- Early asthmatic response (FEV1 fall of ≥ 20%, 0 to 60 minutes after allergen challenge) and LAR (FEV1 fall of ≥15% 3 to 8 hours after challenge). Historical data up to 3 months before enrolment may be used.
- At admission FEV1 should be within 10% of the predicted FEV1 at screening. If subject does not meet this criterion at the first measurement 2 further repeats will be permitted.
Who cannot join
- Subjects who do not conform to the above inclusion criteria.
- Female subjects who are pregnant, trying to become pregnant or lactating.
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary (excluding mild asthma), gastrointestinal, cardiovascular (including ischemic heart disease), hepatic, psychiatric, neurologic, or severe allergies (e.g. anaphylaxis or angioedema).
- Worsening of asthma in the 4 weeks preceding the screening visit (requiring daily use of nebulised β2-agonists or any use of long acting β agonists [LABA], or requiring inpatient hospitalisation for asthma control, or requiring emergency room treatment, or requiring systemic corticosteroids for asthma control) or respiratory infection in the 4 weeks preceding the first screening visit or prior to randomization (Day 1).
- Use of any immunotherapy within 3 months prior to first screening.
- Use of nasal or inhaled corticosteroids, intraophthalmic corticosteroids, nasal, inhaled, or intraophthalmic cromolyn sodium or nedocromil, leukotriene receptor antagonists (zafirlukast, pranlukast, montelukast), and 5-lipoxygenase inhibitors (zileuton) within 28 days prior to first screening and throughout the study.
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- Subject on LABA or short and long acting anti-muscarinics (SAMA or LAMA) see also Section 6.8.
- Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease.
- History of life-threatening asthma, defined as an asthma episode that required intubation or was associated with hypercapnoea, respiratory arrest or hypoxic seizures.
- Symptomatic with allergic rhinitis (e.g., hay fever), requiring treatment, at screening or predicted to have symptomatic allergic rhinitis (e.g., hay fever) during the time of study, requiring treatment.
- History of serious severe hypersensitivity or allergy (e.g., anaphylaxis).
- History of hypersensitivity to budesonide or to any of the excipients.
- Clinically significant abnormalities in physical examination or in laboratory test results (including serum biochemistry, hematology and urinalysis) as assessed by the Investigator.
- Subjects who have received any investigational drug in any clinical trial within 3 months, or who are on extended follow-up.
- Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with anti-epileptic drug(s).
- Subjects who are vegans or have medical dietary restrictions.
- Patients who take concomitant treatment with strong or moderate inhibitors of cytochrome P450 (CYP) 3A4 including oral/systemic ketoconazole, itraconozole, miconazole, clotrimazole, flucanazole, posaconazole, voriconazole, clarithromycin, erythromycin, ciprofloxacin, verapamil, diltiazem, indinavir, nelfinavir, saquinavir, ritonavir, amprenavir, lopinavir, atazanavir, darunavir and cyclosporine.
- Patients who take concomitant treatment with inducers of CYP3A4: carbamazepine, dexamethasone, phenytoin, rifabutin, rifampin and pioglitazone.
- Patients who take concomitant treatment with herbal medication/supplements or St John's Wort.
- Subjects with a supine systolic blood pressure ≥160 mmHg or a supine diastolic blood pressure ≥100 mmHg at screening or prior to randomization.
- History of alcohol abuse (intake of more than 24 units of alcohol per week) or drug addiction as seen on positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines) or positive alcohol test.
- Positive screen on hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus (HIV 1 and 2).
- Clinically significant abnormal 12-lead ECG or one demonstrating QTcB >450 ms at screening.
- Abnormal liver enzymes (alanine aminotransferase >1.5x upper limit of normal [ULN] or total bilirubin >1.5x ULN).
- Subjects who cannot communicate reliably with the Investigator.
- Subjects who are unlikely to co-operate with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles Drug Research Unit at Guy's Hospital
London
About this study
Official title: A Phase IIa Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Multiple Doses of Inhaled RNS60 and Budesonide on the Late Phase Asthmatic Response to Allergen Challenge in Patients With Mild Asthma. (This Study Has Been Amended to no Longer be a Cross Over Study; it Will be a Parallel (RNS60/Placebo) 1 Period Study and no Longer Involves the Administration of Budesonide)
The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1 will be measured after an inhaled allergen challenge at baseline and again after 21 days of treatment.
Read the detailed description
This is a randomized, placebo-controlled, parallel study in approximately 32 male and female subjects with mild asthma. Each subject will receive either the experimental or the placebo, administered as a nebulized dose twice daily for 21 days.
- Conditions
- Asthma
- Being tested
- RNS60, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS60Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| RNS60 | Experimental | RNS60, 4 ml twice daily Receives: Drug: RNS60 |
| Placebo | Placebo comparator | Normal Saline, 4 ml twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in late asthmatic response (LAR) as measured by spirometry
The maximal percentage decrease from the pre-allergen challenge (post-diluent value) in FEV1 between 3 hours and 8 hours post-allergen challenge.
Measured: Baseline and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422121
- Sponsor's protocol ID
- 01.1.1.H3
- Status last verified
- Dec 2016
- First submitted
- 14 Apr 2015
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Multiple Doses of Inhaled RNS60 and Budesonide on the Late Phase Asthmatic Response to Allergen Challenge in Patients With Mild Asthma. (This Study Has Been Amended to no Longer be a Cross Over Study; it Will be a Parallel (RNS60/Placebo) 1 Period Study and no Longer Involves the Administration of Budesonide)
- ClinicalTrials.gov ID
- NCT02422121
- Acronym / sponsor ID
- 01.1.1.H3
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1 will be measured after an inhaled allergen challenge at baseline and again after 21 days of treatment.
Detailed description
This is a randomized, placebo-controlled, parallel study in approximately 32 male and female subjects with mild asthma. Each subject will receive either the experimental or the placebo, administered as a nebulized dose twice daily for 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RNS60 | Experimental | Drug: RNS60RNS60, 4 ml twice daily |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline, 4 ml twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who are able and willing to give written informed consent;
- Male and female subjects aged 18 to 65 years inclusive.
- Subjects with a body weight ≥50 kg and a BMI between 18.0 and 32.0 kg/m2 inclusive at screening.
- Subjects should be steroid-naïve (within 3 months of screening for oral corticosteroids and within 28 days of screening for inhaled corticosteroids) with mild asthma and satisfy the Global Initiative for Asthma (GINA) definition of asthma, but be otherwise healthy.
- Male subjects should agree to not donate sperm from first dose until 3 months post-last dose.
Key exclusion criteria (26 listed)
- Subjects who do not conform to the above inclusion criteria.
- Female subjects who are pregnant, trying to become pregnant or lactating.
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary (excluding mild asthma), gastrointestinal, cardiovascular (including ischemic heart disease), hepatic, psychiatric, neurologic, or severe allergies (e.g. anaphylaxis or angioedema).
- Worsening of asthma in the 4 weeks preceding the screening visit (requiring daily use of nebulised β2-agonists or any use of long acting β agonists [LABA], or requiring inpatient hospitalisation for asthma control, or requiring emergency room treatment, or requiring systemic corticosteroids for asthma control) or respiratory infection in the 4 weeks preceding the first screening visit or prior to randomization (Day 1).
- Use of any immunotherapy within 3 months prior to first screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNS60 | Drug | RNS60 |
| Placebo | Drug | Placebo |
Primary outcome
Change in late asthmatic response (LAR) as measured by spirometry
Time frame: Baseline and Day 21
The maximal percentage decrease from the pre-allergen challenge (post-diluent value) in FEV1 between 3 hours and 8 hours post-allergen challenge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNS60 in people with Asthma, run by Revalesio Corporation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in late asthmatic response (LAR) as measured by spirometry (time frame: Baseline and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.